(139 days)
The Primus US "Apollo" is indicated as a continuous flow anesthesia system. The Primus US "Apollo" may be used for manually assisted, or automatic ventilation, and delivery of gases (O2, N2O and CO2 - in combination with the CO2 module [i.e. Fourth Gas Module]), anesthetic vapor, and monitoring of oxygen and CO2 concentrations, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
The Fourth Gas Module provides an optional means of delivering carbon dioxide (CO2) into the fresh gas coming from the gas mixer of the anesthesia machine Primus US "Apollo".
The Fourth Gas Module consists of a means of flow and pressure control for CO-; a colorcoded control knob; a means of flow and pressure measurement for CO;; a means to mount a CO2 E-size cylinder; and an enclosure for the various components.
The Fourth Gas Module has been verified to provide the Primus US "Apollo" anesthesia workstation (K042607) with a means of delivering carbon dioxide as a medical gas.
I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria for the "Fourth Gas Module with CO2 for Primus US 'Apollo' Anesthesia machine."
The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices. It states:
- "Design, development, verification and validation of the device was performed in accordance with FDA regulations and guidance and company internal standards. The testing and analysis of results provide assurance that the device meets its specifications and is safe and effective for its intended use."
However, it does not provide details about specific acceptance criteria or the study data that supports this assurance.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).